CORE: Study to Evaluate the Conducted AF-Response-Algorithm in Patients Suffering From Heart Failure and Atrial Fibrillation

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE4

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-12-31

Study Completion Date

2007-01-31

Brief Summary

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The Medtronic InSync III Marquis Cardiac Resynchronization Therapy Defibrillator (CRT-D)-System (implantable cardioverter-defibrillator with biventricular stimulation for cardiac resynchronization) is equipped with the "Conducted-Atrial Fibrillation (AF)-Response-Algorithm (CAFR)". This algorithm is designed to maximize biventricular stimulation and thus the amount of cardiac resynchronization when atrial fibrillation occurs. The goal of the study is the evaluation of the effect of the CAFR in CRT-patients suffering from atrial fibrillation by quantification of the increase of biventricular pacing during atrial fibrillation caused by CAFR as well as the influence of the CAFR on the ventricular heart rate.

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Detailed Description

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Conditions

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Heart Failure Sudden Cardiac Death Atrial Fibrillation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Study Groups

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Conducted AF-Response Algorithm (CAFR) On

CAFR: On

* Level medium
* Max. Rate: 110ppm VSR: Off

Group Type EXPERIMENTAL

Conducted AF-Response Algorithm (CAFR) On

Intervention Type DEVICE

Algorithm will be enabled.

Conducted AF-Response Algorithm (CAFR) Off

CAFR: Off VSR: Off

Group Type ACTIVE_COMPARATOR

Conducted AF-Response Algorithm (CAFR) Off

Intervention Type DEVICE

Algorithm will be disabled.

Interventions

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Conducted AF-Response Algorithm (CAFR) On

Algorithm will be enabled.

Intervention Type DEVICE

Conducted AF-Response Algorithm (CAFR) Off

Algorithm will be disabled.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Implant of a Medtronic InSync III Marquis (7279) or later system with Conducted AF-Response

Exclusion Criteria

* Medical reasons that are adverse to participation in the study and compliance by the patient
* Patients who are enrolled in another study or plan to be enrolled into another study
* Pregnant patients or patients who are possibly pregnant due to an unreliable form of contraception

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No